The Bush administration's announcement Tuesday that it was banning the herbal weight-loss supplement ephedra from the marketplace because it represents an unacceptable health risk appears to be a responsible, well-considered decision.
The ban, the federal government's first ever on a dietary supplement, comes eight years after the Food and Drug Administration first began receiving reports that ephedra could be dangerous. Ephedra has been linked to 155 deaths and dozens of heart attacks and strokes, which suggests that use of this dietary supplement to lose weight, enhance athletic performance or by youngsters attempting to emulate professional athletes presents too great a risk to the general public.
Considering that eight years have passed since the first reports questioning the safety of ephedra and three states now require prescriptions for its sale, it cannot be construed that the federal government rushed to judgment in setting down this ban.
Industry watchers believe a court challenge of the government ban is forthcoming. It will be an important test of the 1994 Dietary Supplement, Health and Education Act, sponsored by Sen. Orrin Hatch, R-Utah.
These are issues for a court to sort out, but three factors weigh in the government's favor. The first is its record. The government has never before set down a ban on the sale of a dietary supplement. Then there are the thousands of "adverse incident reports" tied to use of ephedra, and finally the scientific evidence, which shows how the substance works in the body.
As FDA Commissioner Mark McClellan explains, ephedra was declared adulterated because it presents "a significant or unreasonable risk when it's used as labeled."
Yet, manufacturers of ephedra dispute that the dietary supplement — likened to an amphetamine — is a health risk. But debate intensified when Baltimore Orioles pitcher Steve Bechler, 23, died of heatstroke during spring training in Florida this past February. The medical examiner said ephedra contributed to heatstroke.
Bechler's death prompted the FDA to propose warning labels to caution consumers that ephedra had been linked to heart problems and strokes. The product manufacturer posted on its Web site that Bechler was overweight, had high blood pressure and was exercising strenuously in hot, humid weather.
While debates over the science and the role of government in regulating the dietary supplement industry will continue, credit the Bush administration for taking this bold step to protect the public from a potentially risky substance and establishing a strong legal foundation to ensure the ban sticks.